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Periodontal Inflammation and Epigenetics in Obese Individuals

2026年5月20日 更新者：Louisiana State University Health Sciences Center in New Orleans

Association Between Epigenetic Changes, Periodontal Microbiota, And Periodontal Inflammation in Obese Individuals

The goal of this study is to investigate the long-term changes in host epigenetic modifications in obese individuals with periodontitis. The aims of the study are:

• To monitor longitudinal changes in host epigenetic modifiers following non-surgical periodontal therapy in periodontitis patients Study subjects would be categorized into two groups, non-obese with periodontitis, and obese with periodontitis. The study will primarily evaluate changes among these groups cross-sectionally, then longitudinally following non-surgical periodontal therapy (deep cleaning) to determine if any changes occur with treatment.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Periodontitis is an inflammatory disease process primarily caused by microorganisms, which affects the tooth-supporting structures and can eventually lead to tooth loss. Oral health is a reflection of general health. Accordingly, obesity can influence periodontitis and increase its severity. The study participants will be categorized into two groups as described above. Enrolled participants will be balanced for distribution of age, gender, ethnicity, and general health.

The objective of this pilot study is to investigate the cross-sectional and longitudinal changes in host epigenetic modifications in obese individuals with periodontitis. The investigators intend to examine these host epigenetic changes in obese and non-obese individuals with both periodontal health and periodontitis. The study will primarily evaluate longitudinal changes following non-surgical periodontal therapy (considered the gold standard for the initial treatment of periodontitis) to determine whether any modifications occur with treatment.

To control for other factors affecting periodontitis, the investigators plan to exclude diabetic participants, document oral hygiene habits, and monitor periodontal microorganisms and inflammatory mediators in the groups for further associations. In summary, the study will identify important epigenetic signatures in obese participants with periodontal disease compared to those with periodontal health as a potential causal factor linking the two conditions.

The investigators hypothesize that epigenetic programs in obese individuals will influence the severity of periodontal disease by altering inflammatory pathways and the microbial environment.

研究类型

介入性

注册 (估计的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Vinayak M Joshi, PhD, MS
  • 电话号码：15049418280
  • 邮箱：vjosh1@lsuhsc.edu

研究联系人备份

  • 姓名：Jeanne St.Germain, RDH, B.S.
  • 电话号码：504-941-8276
  • 邮箱：jstge1@lsuhsc.edu

学习地点

  • 美国
    • Louisiana
      • New Orleans、Louisiana、美国、70119
        • LSU Health Science Centre, School of Dentistry
        • 接触：
        • 接触：
          • Jeanne St.Germain, RDH, B.S.
          • 电话号码：504-941-8276
          • 邮箱：jstge1@lsuhsc.edu

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Adults aged ≥18 years,
  • No history of periodontal therapy in the last 6 months,
  • No use of tobacco,
  • No history of pregnancy lactation or contraceptive medication.
  • Need to have a minimum of 20 teeth.

Exclusion Criteria:

  • Had antimicrobial/antiviral therapy in the previous 3 months,
  • History of uncontrolled diabetes,
  • History of rheumatoid arthritis,
  • History of osteoporosis,
  • History of oral cancer,
  • Currently taking hormonal contraception,
  • If pregnant or lactating currently or prior 6 months,
  • Subjects on current weight loss drugs
  • If planning weight reduction surgery during the time of the study
  • Any other condition, disease or therapy with documented influence on oral inflammation and/or oral microbial environment.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：基础科学
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：non-obese with periodontitis
Non-surgical periodontal therapy will be administered
程序：Non-surgical periodontal therapy will be administered
Non-surgical periodontal therapy (Deep cleaning-SRP): The deep cleaning by a scaling and root planing (SRP) procedure, is the standard initial treatment for all individuals diagnosed with periodontitis (periodontal disease). At the initial treatment planning appointment, each subject will receive intra-oral and extra-oral examination along with full mouth examination of the periodontal status, followed by diagnosis and treatment planning. The subject will then be scheduled for a deep cleaning procedure. The Deep cleaning procedure are carried out using hand instruments and ultrasonic instruments.
其他名称：
  • 刮治和根面平整
有源比较器：obese with periodontitis
Non-surgical periodontal therapy will be administered
程序：Non-surgical periodontal therapy will be administered
Non-surgical periodontal therapy (Deep cleaning-SRP): The deep cleaning by a scaling and root planing (SRP) procedure, is the standard initial treatment for all individuals diagnosed with periodontitis (periodontal disease). At the initial treatment planning appointment, each subject will receive intra-oral and extra-oral examination along with full mouth examination of the periodontal status, followed by diagnosis and treatment planning. The subject will then be scheduled for a deep cleaning procedure. The Deep cleaning procedure are carried out using hand instruments and ultrasonic instruments.
其他名称：
  • 刮治和根面平整

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Host-specific epigenetic signatures
大体时间：Baseline/Day 1
Gingival crevicular fluid and saliva will be analyzed to study epigenetic signatures
Baseline/Day 1
Inflammatory cytokine profiles
大体时间：Baseline/Day 1
Gingival crevicular fluid and saliva will be analyzed to study inflammatory cytokine profiles.
Baseline/Day 1
Periodontal microbial composition
大体时间：Baseline/Day 1
Subgingival plague will be analyzed to study periodontal microbial composition
Baseline/Day 1

次要结果测量

结果测量
措施说明
大体时间
Host epigenetic modifiers pre- and post-therapy
大体时间：Baseline/Day 1, Day 30, Day 90
Gingival crevicular fluid and saliva will be analyzed to study epigenetic changes.
Baseline/Day 1, Day 30, Day 90
Inflammatory cytokine changes pre- and post-therapy
大体时间：Baseline/Day 1, Day 30, Day 90
Gingival crevicular fluid and saliva will be analyzed to study inflammatory cytokine changes.
Baseline/Day 1, Day 30, Day 90
Periodontal microbial changes pre- and post-therapy
大体时间：Baseline/Day 1, Day 30, Day 90
Subgingival plague will be analyzed to study periodontal microbial changes.
Baseline/Day 1, Day 30, Day 90

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Louisiana State University Health Sciences Center in New Orleans

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月25日

初级完成 (估计的)

2026年12月30日

研究完成 (估计的)

2026年12月30日

研究注册日期

首次提交

2025年12月19日

首先提交符合 QC 标准的

2026年5月20日

首次发布 (实际的)

2026年5月28日

研究记录更新

最后更新发布 (实际的)

2026年5月28日

上次提交的符合 QC 标准的更新

2026年5月20日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 8320 (New York State Psychiatric Institute Institutional Review Board)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Aggregated data will be published as a peer reviewed manuscript.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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